CoTherix Inc announced that its New Drug Application (NDA) for Ventavis (iloprost) Inhalation Solution has been accepted for review by the US Food and Drug Administration and has been granted priority review designation.
The priority review designation establishes a target action date of December 31, 2004, for the Ventavis NDA. Additionally, CoTherix's request for orphan drug designation has been granted for the use of Ventavis to treat pulmonary arterial hypertension.
Ventavis is an inhaled formulation of iloprost, a prostacyclin analog. CoTherix is developing Ventavis for the treatment of pulmonary arterial hypertension, a highly debilitating disease characterized by severe constriction of the blood vessels of the lungs. Ventavis is currently marketed in various European countries and Australia by Schering AG, Germany.
CoTherix licensed the exclusive US rights to Ventavis from Schering AG in October 2003.
CoTherix Inc is a biopharmaceutical company focused on licensing, developing and commercializing therapeutic products for the treatment of cardiopulmonary and other chronic diseases.